Sunday, May 16
10:00 am - 1:00 pm
(SC3) PROGRAM MANAGEMENT FOR SCIENTISTS
Congratulations! You have been promoted to Program Manager. Now what? Can your bench-top scientific experience in proteins - expression, characterization, development of protein-based therapeutics, bioprocessing, etc. - lead to success in people/business management? Most scientists train for years in their prospective fields but must learn business management “on-the-fly.” This course is designed for scientists who have recently been promoted to program/product manager or are planning ahead.
Course Instructor:
 Patricia Seymour, M.B.A., Senior Consultant, BioProcess Technology Consultants
Patricia Seymour has over 20 years of experience in the biotechnology industry. Her expertise spans the development and commercialization spectrum, including biologics and small molecule development and manufacturing, supply chain strategy and management and operations leadership. Her current activities include: developing overall CMC strategies for diverse product pipelines, developing and implementing outsourcing strategies, managing outsourced process development and manufacturing activities from drug substances through to distribution, steering clients through CMC regulatory requirements and overall CMC operations including project management and budgeting. Prior to joining BioProcess Technology Consultants, Ms. Seymour was Senior Director, Global Investigational Supply Operations at Millennium Pharmaceuticals, Inc., where she worked with other senior leaders to develop and implement CMC strategies including outsourcing. She was previously Director of Business Development at Covance Biotechnology Services (now Diosynth) where her responsibilities included negotiating contact manufacturing projects. As Senior Director, Corporate Development at Collaborative BioAlliance she was instrumental in launching the new contract manufacturing business unit. Before Collaborative, Ms. Seymour held research and development positions at ImmunoGen, Dana Farber and Sloan Kettering. Ms. Seymour received her B.S. from Villanova University and her M.B.A. from Boston University. Ms. Seymour is Certified Supply Chain Professional (APICS).
2 PM - 6 PM
(SC6) ANALYTICAL TOOLS AND METHODS USED IN BIOPHARMACEUTICAL CHARACTERIZATION TO DRIVE THERAPEUTIC DRUG DESIGN
Overview of the common analytical techniques used for performing a structural assessment of biopharmaceuticals, with real-life examples highlighting how they are applied Speakers are leaders in structural characterization for biopharmaceutical drug development, and bring a wide breath of experience to the forum Discussion will span a range of topics from protein profiling for isoform detection and percent population to peptide mapping for detecting low-level changes to drug product and the identification of post-translational modifications Additionally, methods for looking at solvent accessibility and epitope mapping will be presented
Course Instructors:
Jennifer F. Nemeth, Ph.D., Head, Discovery Mass Spectrometry, Centocor R&D, Inc.
Steve Pomerantz, Ph.D., Senior Research Scientist, Centocor R&D, Inc.
Jason C. Rouse, Ph.D., Director, Mass Spectrometry, Analytical Research and Development, Pfizer, Inc.
Sharon Gao, Ph.D., Principle Scientist, Analytical Biochemistry, Biogen Idec
Paul Schnier, Ph.D., Molecular Structure & Design, Amgen, Inc.
AGENDA
2:00 Introduction, Clarification of Goals, Understanding the Audience
Chair: Jennifer F. Nemeth, Ph.D., Head, Discovery Mass Spectrometry, Centocor R&D Inc.
2:15 Introductory Presentation
An Overview of the Analytical Techniques Used for Structural Characterization of Biopharmaceutical Drug Candidates
Jennifer F. Nemeth, Ph.D., Head, Discovery Mass Spectrometry, Centocor R&D Inc.
There are a wide range of biopharmaceutical drugs, which range in molecular type including peptides, proteins, and antibodies. The biopharmaceutical arena presents a unique set of challenges, compared to the small molecule field, for structural analysis; and therefore, a unique set of analytical techniques are needed to characterize these molecules. Some of the most common techniques include SDS-PAGE and size-exclusion chromatography for general protein size, aggregation, and purity assessment, to N-terminal sequencing for purity and terminal assessment, to mass spectrometry for mass assessment, isoform heterogeneity, and post-translational modification identification and localization. An overview of these techniques, and how they might be applied to characterize biopharmaceuticals, is presented
2:45 Enhanced Utility of the Advion Triversa Ion Source for Protein Characterization in the Biopharmaceutical Industry
Steve Pomerantz, Ph.D., Senior Research Scientist, Centocor R&D Inc.
Since its introduction, the Advion Nanomate chip-based ESI source has been principally marketed to the pharmaceutical industry as a means of obtaining high-throughput and high-sensitivity analyses with minimal cross-talk. However, the instrument has several very desirable features for the Drug Discovery researcher. Specifically, the ability to disentangle complex mixtures by effectively lengthening the chromatographic time-scale is invaluable for the identification of low-level post-translational modifications (PTMs) of both target and biopharmaceutical drug product. The use of the Triversa ion source in all of its operating (LC/MS, fraction collector, infusion MS(/MS)) modes for the in-depth PTM characterization of complex mixtures will be presented.
3:15 Profiling Intact Proteins by High-resolution Mass Spectrometry: Key Applications in the Discovery, Development, Commercialization, and Manufacturing of Biopharmaceuticals
Jason C. Rouse, Ph.D., Director - Mass Spectrometry, Analytical Research and Development, Pfizer, Inc.
3:45 Interactive Panel with All Faculty
4:15 Break
4:30 Structural Fingerprinting of Intact Heterogeneous Proteins Using Traveling Wave Ion Mobility Tandem Mass Spectrometry
Paul Schnier, Ph.D., Molecular Structure & Design, Amgen Inc.
Therapeutic proteins produced by recombinant DNA technologies are often heterogeneous due to a variety of modifications. Monitoring these molecules for alterations in either primary sequence or post-translational modifications from cell culture to final product is important as mutations and chemical modifications can compromise product quality and efficacy. Here we demonstrate how ion mobility and tandem mass spectrometry can be used to simplify the spectra of large protein ions and enable top down characterization of intact glycoproteins and monoclonal antibodies.
5:00 Assessment of Oxidation/Deamidation/other PTMs in Biopharmaceuticals
Sharon Gao, Ph.D., Principle Scientist, Analytical Biochemistry, Biogen Idec
Deamidation, oxidation and fragmentation are major degradation pathways for biopharmaceuticals. These modifications can significantly alter drug product quality and efficacy. Here we present methods that accurately determine these critical attributes and discuss the impact of deamidation on binding kinetics.
5:30 Interactive Panel with All Faculty
6:00 Close of Short Course
*Separate Registration Required
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